Psychological Treatment in Psychiatric Inpatient Care.

NCT ID: NCT06702254

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-05
• Study Completion Date: 2024-06-30

Brief Summary

There is a lack of psychological treatments within inpatient psychiatric care while there is support for active psychological interventions having an effect on psychiatric problems. The purpose of the present feasibility study is to test whether a psychological treatment based on Cognitive Behavioral therapy (CBT) and Acceptande and Commitment therapy (ACT) for patients in psychiatric inpatient care is acceptable, understandable, helpful and effective both for patients and the staff who carry out the treatment. The therapist in the project will receive training and on-going supervision in a CBT-manual created within the research group.

Detailed Description

The main questions the study aims to answer are:

1. Is cognitive behavioral therapy perceived as acceptable, comprehensible and helpful for patients in psychiatric inpatient ´care, when given by nursing staff in inpatient care?

2. Is cognitive behavioral therapy perceived as acceptable, understandable and helpful to the nursing staff who provided the treatment intervention?

3. Is cognitive behavioral therapy effective in reducing psychiatric symptoms such as depression, anxiety, and perceived health status for patients in psychiatric inpatient care when provided by nursing staff?

Participants are nursing staff from eight psychiatric inpatient wards and patients. The training consists of a two day workshop in the CBT manual followed by eight group supervision sessions parallell with patient treatment.

The patients are offered a CBT manual based psychological intervention with planned four treatment sessions but these can be flexibly prolonged to more sessions for repetition for patients staying for a longer period of time.

The study is a quasi-experimental design. Randomization takes place at ward level. The wards will be twin-matched based on patient problems and then randomized to treatment as usual (control group) or treatment as usual plus a CBT intervention (experimental group). Eight wards are included. Four wards will thus act as a control group and four wards as an experimental group. All within inpatient-care at Region Stockholm. The study aimed to include a total of 230 participants during 2020-2023. With a distribution ratio of 1:2, 77 participants are allocated to the experimental group and 153 participants to the control group, calculated on the basis of an expected effect size of 0.35 and a power of 0.8.

Patients who fulfill the inclusion criteria are informed about the study orally and in writing and are offered participation. Informed consent is collected upon offer of participation in the study. Patients are included consecutively as long as the ward and therapists have the available resources to accept more participants. Patients fill in self-report forms in connection with the usual enrollment and discharge routine. The self-report forms are questions about anxiety symptoms (GAD-7); perception of health (EQ-5D); depression symptoms (PHQ-9): experience of the intervention; Behavioral Activation Depression Scale-Short Form (BADS-SF); patient satisfaction. For the qualitative part with in-depth interviews, approx. 20 nursing staff are recruited. Semi-structured interview guide for nursing staff is created.

Conditions

Anxiety and Depression; Psychiatric Inpatients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treament as usual

The in-ward patient are provided treatment as usual. This can include medication, routine brief conversation and ward activity.

Group Type: OTHER

Treatment as usual

Intervention Type: OTHER

This treatment as usual can consist of medication, brief talks, leisure activity on the wards.

Psychological manualized treatment with CBT and ACT

The intervention is based on a manual and is an add-on to treatment as usual. In-ward patients are offered a brief psychological treatment based on core features from CBT and ACT such as behavioral activation and work on values and unhelpful thoughts. Prior to the intervention nursing staff receive training in the manual followed by supervision during the treatment intervention. The treatment in this condition is an add-on to usual treatment given in the wards. The intervention is brief up to four sessions in the manual but can be shortened or extended to fit the patients admission time.

Group Type: EXPERIMENTAL

Experimental: Psychological manualized treatment with CBT and ACT

Intervention Type: BEHAVIORAL

The intervention is brief and centered around four therapeutic sessions that can be extended or shortened depending on how long patients are hospitalized. Core techniques from CBT and ACT are included in the manual and consists of behavioral activation and values and unhelpful thoughts. Nursing staff on these wards have received training in the manual parallel with supervision which is not given in the treatment as usual wards. The wards that have not received the intervention will be offered this at the end of their TAU period.

Interventions

Experimental: Psychological manualized treatment with CBT and ACT

The intervention is brief and centered around four therapeutic sessions that can be extended or shortened depending on how long patients are hospitalized. Core techniques from CBT and ACT are included in the manual and consists of behavioral activation and values and unhelpful thoughts. Nursing staff on these wards have received training in the manual parallel with supervision which is not given in the treatment as usual wards. The wards that have not received the intervention will be offered this at the end of their TAU period.

Intervention Type: BEHAVIORAL

Treatment as usual

This treatment as usual can consist of medication, brief talks, leisure activity on the wards.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Meet criteria for and are enrolled in psychiatric inpatient care.
• Agree to participate in the study.
• Assessed to be stable enough to participate in a conversation after a routine ward medical assessment (do they understand what they are agreeing to/not to, can communicate, etc.)

Exclusion Criteria

• Other ongoing intensive psychotherapy (e.g. in outpatient care that continues during the psychiatric inpatient care stay).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lena Reuterskiold

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lena Reuterskiöld PhD

Role: PRINCIPAL_INVESTIGATOR

Region Stockholm

Locations

Psykiatri Nordväst

Stockholm, Sweden, Sweden

Countries

Sweden

Other Identifiers

2020-01169

Identifier Type: -

Identifier Source: org_study_id